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FCSC Working Group 4

A figure with two panels. Left panel shows the activities of WG4-ILS1 physical titer, WG4-ILS2 infectious titer, and WG4-ILS3 purity, as funneling into the result of measurement assurance for gene delivery systems and potential generation of standard methods, reference materials or reference data. Right panel shows the activities of WG4-ILS1 that will be distributed to labs through sharing contributed materials for measurements of genome titer, capsid titer, particle concentration, and other methods.

WG4 Interlaboratory Study Activities.  A. Multiple interlaboratory studies are planned to support gene delivery system measurement assurance.  B. WG4-ILS1 study activities are focused on physical titer measurements.

Gene Delivery Systems

Working Group 4 (WG4) efforts are focused on identifying and minimizing the sources of variability in assays of gene delivery systems including adenoviral vectors, adeno-associated viral vectors, lentiviral vectors, lipid nanoparticles and extracellular vesicles.  Consensus-based methods, reference materials, and reference data are expected to be made available to the community from these efforts.  Activities in progress include:

  1. An interlaboratory study on physical titer measurement of gene delivery systems WG4 is actively planning its first interlaboratory study (WG4-ILS1) on physical titer measurements of gene delivery systems including genomic titer, capsid titer, particle concentration, and other novel and/or orthogonal physical titer methods.  Future interlaboratory studies will be conducted for functional titer measurements and particle preparation purity (full/partial/empty) characterization.
  2. International documentary standards participation Working group members are participating in the development of international documentary standards through ISO.  Standards under active development with WG4 participation include:

Contacts

Working Group 4 Technical Leads

Consortium Principal Investigator

Created November 29, 2024